Device Classification Name |
Instrument, Manual, Specialized Obstetric-Gynecologic
|
510(k) Number |
K940907 |
Device Name |
MADDEN SURGICAL THIMBLE |
Applicant |
KELLEY-GILMER MEDICAL CORP. |
617 BROAD ST. |
SELMA,
AL
36701
|
|
Applicant Contact |
MEL GILMER |
Correspondent |
KELLEY-GILMER MEDICAL CORP. |
617 BROAD ST. |
SELMA,
AL
36701
|
|
Correspondent Contact |
MEL GILMER |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 02/24/1994 |
Decision Date | 12/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|